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Cohort Network for Adolescents and Youth With multipLe Mental Health Conditions (CALM)

7. července 2026 aktualizováno: Centre for Addiction and Mental Health

Cohort Network for Adolescents and Youth With multipLe Mental Health Conditions (CALM): A Master Observational Trial

The Cohort Network for Adolescents and Youth With multipLe Mental Health Conditions (CALM) Master Observational Trial is a prospective, longitudinal observational study that seeks to improve clinical care for youth with multiple mental health conditions (MMHC), also known as mental health multimorbidity in the literature. MMHC is conceptualized as the presence of two or more mental health diagnoses under the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). MMHC is common in youth seeking mental health services and is associated with less favorable outcomes and greater health services utilization. Mental health disorders also accumulate in youth over time. The Master Observational Trial (MOT) will investigate MMHC in critical developmental periods in youth and identify risk and protective factors that will provide a mechanistic understanding of how MMHC develops over time. A subset of participants will also enroll in a Deep Phenotyping Cohort, which includes enhanced clinical and cognitive assessments and multimodal neuroimaging to investigate neurobiological mechanisms underlying MMHC and identify potential biomarkers of illness complexity and progression.

In the near future, we aim to add to the current protocol to embed both a clinical trials network for youth mental health in Ontario and Calgary within the CALM study and add digital phenotyping using wearable technology to generate digital and physiological markers of MMHC. The current protocol focuses on establishing the longitudinal MOT cohort and Deep Phenotype Cohort only as a first step towards these long term CALM goals.

Přehled studie

Postavení

Nábor

Podmínky

Detailní popis

The primary objectives of the CALM MOT are to:

  1. Establish a prospective, longitudinal cohort of children and youth aged 11-24 years to characterize the progression and outcomes of MMHC over time.
  2. Facilitate later development of a clinical trials network and clinical research in MMHC with a focus on developing transdiagnostic interventions and improving care.
  3. Establish a deeply phenotyped cohort of youth in a subset of participants enrolled in the MOT (light phenotyping protocol), using multidimensional, multilevel data to investigate brain-based mechanisms of MMHC with potential for biomarker discovery.

Specific objectives of the Deep Phenotyping Cohort are to:

  1. Collect data across CALM sites in participants that are eligible and consent to participate in CALM MOT Light and the Deep Phenotyping Protocol. In this subset of CALM participants, we will extend the clinical/behavioural measurement battery, and collect high quality cognitive and multimodal (T1, multi-shell DWI, resting state, ASL) neuroimaging data that will be undertaken as part of the CALM baseline deep phenotyping protocol.
  2. Use open access brain age and centile score calculators using unimodal brain imaging data to examine centile score distributions for various data samples in a sex stratified manner (e.g., clinical/community ascertained) and associations between centile scores with behavioral/cognitive indices of clinical severity/impairment and MMHC (e.g., MMHC index). Available open access normative and clinically enriched neuroimaging samples that overlap with the proposed CALM sample age range (11-24 years) will be utilized.
  3. Undertake analysis using cross-sectional neuroimaging and longitudinal MOT data derived from the CALM network to test whether deviations from normative brain measures using either unimodal or integrating data from different imaging sequences (i.e., multimodal), imaging calculators may have utility as a baseline 'prognostic/predictive' marker of youth who may have more complex illness (i.e., MMHC) at the time of initial (baseline) participation in the CALM study and at subsequent time points and/or may be less responsive to clinical interventions.

Typ studie

Pozorovací

Zápis (Odhadovaný)

1620

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T2N 1N4
        • Nábor
        • University Of Calgary
        • Kontakt:
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Paul Arnold, MD, PhD, FRCPC
    • Ontario
      • Hamilton, Ontario, Kanada, L8L 2X2
        • Nábor
        • McMaster Children's Hospital, Hamilton Health Sciences
        • Kontakt:
          • Melissa Kimber, BA, BSW, MSW, PhD
          • Telefonní číslo: 27220 905-525-9140
          • E-mail: kimberms@mcmaster.ca
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Melissa Kimber, BA, BSW, MSW, PhD
      • Ottawa, Ontario, Kanada, K1Z 7K4
        • Nábor
        • The Royal Ottawa Mental Health Centre
        • Vrchní vyšetřovatel:
          • Jennifer Phillips, PhD
        • Kontakt:
        • Kontakt:
      • Ottawa, Ontario, Kanada, K1H 8L1
        • Nábor
        • Children's Hospital of Eastern Ontario Research Institute
        • Kontakt:
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Gary Goldfield, PhD, C. Psych.
        • Vrchní vyšetřovatel:
          • Nicole Racine, PhD, C. Psych.
      • Toronto, Ontario, Kanada, M5G 1X8
      • Toronto, Ontario, Kanada, M6J1H4
        • Nábor
        • Centre for Addiction and Mental Health (CAMH)
        • Kontakt:
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Stephanie Ameis, MD, MSc, FRCPC

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

The CALM network will recruit children and youth aged 11-24 who have sought, are seeking, or are accessing mental health care from 5 partner sites in Ontario (Centre for Addiction and Mental Health, Hospital for Sick Children, McMaster Children's Hospital, Children's Hospital of Eastern Ontario, and The Royal Ottawa Mental Health Centre) and 1 partner site in Alberta (Alberta Health Services) as well as the broader community.

Caregivers of CALM participants will be asked to complete caregiver specific questionnaires (self-report and completing the measures based on their child/youth). When a CALM child/youth participant is approached for the study, we will ask said participant if we can contact their caregiver to participate in the study. We will then approach the caregiver for consent. No external recruitment of non-CALM participants caregivers will be implemented.

Popis

Inclusion Criteria:

The participant must meet all of the inclusion criteria to be eligible for this research study:

  • Light Phenotype Eligibility Must sign and date the informed consent form, or provide assent and have a Substitute Decision Maker provide informed consent; Aged 11-24 years old at the time of screening; Any person within age criteria who has previously sought, is seeking, or is accessing mental health services; Are able to complete assessments in English.

Deep Phenotype Eligibility Must be part of the CALM light phenotype cohort; Must sign and date the deep phenotyping informed consent form, or provide assent and have a Substitute Decision Maker provide informed consent.

Light Phenotype Caregiver Participant Eligibility:

Any caregiver of a CALM child/youth participant is eligible to participate in the study, insofar as the child/youth participant has consented to the light phenotype cohort and has agreed for their caregiver to be contacted to participate in the study; Must sign and date the informed consent form.

Deep Phenotype Caregiver Participant Eligibility:

Any caregiver of a CALM child/youth participant is eligible to participate in the study, insofar as the child/youth participant has consented to the deep phenotype cohort and has agreed for their caregiver to be contacted to participate in the study; Must sign and date the informed consent form.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this research study:

Light Phenotype Does not provide informed consent (for those with the capacity to consent) or assent (for those who lack the capacity to consent); For those individuals who lack the capacity to consent, the inability of the parent/legal guardian to provide informed consent for the youth is also an exclusion criterion; Those who lack capacity to consent include individuals who are non-verbal or unable to speak any English.

Deep Phenotype Unable to participate in deep phenotyping protocol (e.g., MRI contraindication, uncorrected vision or hearing impairments that would interfere with data collection, unwillingness to complete assessments); No exclusion criteria are based on race, ethnicity, sex or gender.

Light Phenotype Caregiver Participant Ineligibility:

Caregivers of CALM child/youth participants are ineligible to participate in the study if:

The child/youth participant does not agree for their caregiver to be contacted to participate in the study; The child/youth participant is not participating in the light phenotype cohort; Does not provide informed consent (for those with the capacity to consent). Those who lack capacity to consent include individuals who are non-verbal or unable to speak any English.

Deep Phenotype Caregiver Participant Ineligibility:

Caregivers of CALM child/youth participants are ineligible to participate in the study if:

The child/youth participant does not agree for their caregiver to be contacted to participate in the study; The child/youth participant is not participating in the deep phenotype cohort (i.e., is only participating in the light phenotyping cohort); Does not provide informed consent (for those with the capacity to consent). Those who lack capacity to consent include individuals who are non-verbal or unable to speak any English.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
MOT

In the MOT/Light Protocol, clinical, and functional measures will be collected in addition to blood-based 'omics' including proteomic (immune markers) and genomic analysis of DNA derived from blood and/or saliva. Over 3 years n=1620 children and youth will be recruited to the MOT/Light Protocol across the CALM Network.

A number of measures will be collected throughout the course of the study in order to capture symptoms across a spectrum of conditions in the target population. Provided that the main objective of the CALM project is to improve clinical care for youth with a particular focus on MMHC, it is vital to use validated standardized assessments that test highly prevalent physical and mental health conditions. MOT/Light measures will be collected via self-report (SR), rated-administered (RA), caregiver-administered (Ca), or a combination
Deep Phenotyping
Multidimensional, multilevel data will be obtained in a subcohort of CALM Study youth (3 years n=~614) recruited to the MOT who also consent to participate in the Deep Phenotyping protocol. The Deep Phenotyping Protocol includes additional clinical, behavioural, developmental and functional outcomes, not collected as part of the light phenotyping battery as well as the collection of neurocognitive measures and neuroimaging data. Cognitive phenotyping will be administered at 0 and 6 month time points. Neuroimaging will be collected at one time point, harmonized across sites using human connectome quality scanning and to key external initiatives (e.g., neuroimaging via ABCD) facilitating secondary data use, and the utilization of additional cohorts in analysis.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Diagnostic Assessment for the Health Spectrum
Časové okno: Baseline and 24 months
The Diagnostic Assessment for the Health Spectrum (DASH) is a semi-structured screener and interview that evaluates a broad range of psychiatric symptoms and associated symptoms. It also assesses a number of physical health symptoms. The DASH is based on the core structure of the Schedule for Affective Disorders and Schizophrenia-SADS and Kiddie-SADS, and includes features of a number of other structured interviews of psychopathology. It provides a diagnostic spectrum in addition to categorical diagnoses that are aligned to the DSM-IV and DSM-5. The completed interview yields a narrative report and summary for clinicians and researchers. There are three versions (adult, child, and parent on child) which take approximately 90-240+ minutes to complete.
Baseline and 24 months
Adolescent Health History
Časové okno: Baseline, 12 months, 24 months
Youth and caregivers will be asked to self-report the presence of health conditions using the Adolescent Health History measure to indicate whether the youth has in the past or currently has any of over 40 common mental or physical health conditions listed. Youth will also be able to add up to four other conditions not listed.
Baseline, 12 months, 24 months
Assessment of Quality of Life
Časové okno: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months

The Assessment of Quality of Life (AQoL) measures 5 dimensions: illness, independent living, social relationships, physical senses and psychological well being. Each dimension is measured by three items (a total of 15 items).

Total scores can range from a minimum of 20 to a maximum of 99, with higher scores indicating poorer quality of life.
Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Brain-CODE Demographic Form
Časové okno: Baseline, 12 months, 24 months
The Brain-CODE Demographic Form is a standard form developed by Brain-CODE to capture demographic information from participants.
Baseline, 12 months, 24 months
Brain-CODE Medical History Form incorporating Developmental History Questionnaire (DHQ) Items
Časové okno: Baseline, 12 months, 24 months
The Brain-CODE Medical History Form is a standard form developed by Brain-CODE to capture medical history in participants.
Baseline, 12 months, 24 months
Canadian Health Survey on Children and Youth (CHSCY) Childhood Experiences Scale
Časové okno: Baseline, 12 months, 24 months
The Canadian Health Survey on Children and Youth (CHSCY) Childhood Experiences Scale includes 10 items assessing youth's self-reported exposure to different forms of maltreatment by their caregivers, including physical, sexual and emotional abuse, neglect, as well as exposure to violence between caregivers. One additional item captures youth's exposure to corporal punishment. Items have been administered in population-based studies that include samples of youth and adults, as well as clinical observational studies and trials. Total scores can range from a minimum of 10 to a maximum of 50, with higher scores indicating more negative experiences.
Baseline, 12 months, 24 months
Child and Youth Resilience Measure
Časové okno: Baseline, 12 months, 24 months, 36 months
The Child and Youth Resilience Measure is a screening tool to explore the resources (individual, relational, communal and cultural) available to individuals that may bolster their resilience. Individuals aged 24+ will be asked to complete the Adult Resilience Measure. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.
Baseline, 12 months, 24 months, 36 months
The Columbia Suicide Severity Rating Scale
Časové okno: Baseline, 24 months
The Columbia Suicide Severity Rating Scale is a validated and widely used rater-administered measure of suicidal ideation and behaviour, and non-suicidal self-injury. It will be administered to all participants. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.
Baseline, 24 months
Self-Injurious Thoughts and Behaviours Interview
Časové okno: Baseline, 24 months
The Self-Injurious Thoughts and Behaviours Interview (SITBI) measures self-injurious thoughts and behaviors.
Baseline, 24 months
Canadian Health Survey on Children and Youth (CHSCY) Bullying Scale
Časové okno: Baseline, 12 months, 24 months
The Canadian Health Survey on Children and Youth (CHSCY) Bullying Scale includes 10 items and is designed to assess youth exposure to bullying in the preceding 12 months. Items capture both the type and frequency of bullying, with types of bullying covered by the measure including verbal, physical, relational, and online forms of bullying. Response options are captured on an ordinal scale encompassing: Never, A few Times a Year, Monthly, Weekly, Daily. Total scores can range from a minimum of 10 to a maximum of 50, with higher scores indicating more experiences with bullying.
Baseline, 12 months, 24 months
Difficulties in Emotion Regulation Scale Short Form
Časové okno: Baseline, 12 months, 24 months, 36 months
The Difficulties in Emotion Regulation Scale Short Form is an 18-item measure used to identify emotional regulation issues. The measure covers 4 dimensions of emotional regulation: awareness and understanding of emotions; acceptance of emotions; the ability to engage in goal-directed behavior and refrain from impulsive behavior when experiencing negative emotions; and access to emotion regulation strategies perceived as effective. Total scores can range from a minimum of 18 to a maximum of 90, with higher scores indicating more difficulties with emotion regulation.
Baseline, 12 months, 24 months, 36 months
Eating Disorder Examination Questionnaire (EDE-QS) Short Form
Časové okno: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The Eating Disorder Examination Questionnaire (EDE-QS) Short Form is a 12-item, self-report questionnaire capturing eating disorder symptoms. Response options are anchored on a 4-point ordinal response scale that captures symptoms over the preceding 7 days. Total scores can range from a minimum of 0 to a maximum of 36, with higher scores indicating the presence of more eating disorder symptoms.
Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
General Anxiety Disorder-7
Časové okno: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
The General Anxiety Disorder-7 (GAD-7) measures presence and severity of Generalized Anxiety Disorder. Total scores can range from a minimum of 0 to a maximum of 21, with higher scores indicating greater presence and severity of anxiety symptoms.
Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
General Behaviour Inventory-10 Mania
Časové okno: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
The General Behaviour Inventory-10 Mania measures the presence and severity of mania. Total scores can range from a minimum of 0 to a maximum of 30, with higher scores indicating greater presence and severity of mania.
Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
General Life Satisfaction
Časové okno: Baseline, 18 months, 30 months
A singular question from the Canadian Social Survey - Quality of Life and Energy Consumption Behaviours measure will be administered to determine life satisfaction. Total scores can range from a minimum of 0 to a maximum of 10, with higher scores indicating greater life satisfaction.
Baseline, 18 months, 30 months
The Goal-Based Outcome (GBO) Tool
Časové okno: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The Goal-Based Outcome (GBO) Tool aims to measure the progress and outcomes of an intervention in a simple way. It can be applied in any setting and is currently available in 9 languages. The child GBO tool contains a record sheet whereby up to 3 goals with their descriptions can be written down, followed by a goal rating sheet with descriptions and a scale ranging from 0 (Goals not at all met) to 10 (Goal reached). A goal progress chart at the end can be used to rate the progress of the goal across 12 sessions.
Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Internalized Stigma of Mental Illness
Časové okno: Baseline
The Internalized Stigma of Mental Illness (ISMI) scale is a questionnaire measuring self-stigma among persons with psychiatric disorders. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.
Baseline
International Sedentary Assessment Tool
Časové okno: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
This measure consists of two parts. The first part has six items, and asks questions based on typical weekday activity in the last week. The second part also includes six items and asks questions pertaining to typical weekend activities within the last week. Higher scores equate to more sedentary behaviors in a participant.
Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
McMaster Family Functioning Scale
Časové okno: Baseline, 12 months, 24 months, 36 months
The McMaster Family Functioning Scale is a shorter 12-item assessment developed from The McMaster Family Assessment Device, which is a 60-item questionnaire that measures an individual's perceptions of their family. Total scores can range from a minimum of 12 to a maximum of 48, with higher scores indicating more positive perceptions of family.
Baseline, 12 months, 24 months, 36 months
Treatment Log
Časové okno: Baseline, 6 months, 18 months, 24 months, 30 months, 36 months, 42 months
This inventory records prescribed treatment and medication, adherence and tolerability every 6 months.
Baseline, 6 months, 18 months, 24 months, 30 months, 36 months, 42 months
Ohio State University Traumatic Brain Injury Identification Method
Časové okno: 3 months, 30 months
The Ohio State University Traumatic Brain Injury Identification Method measures a participant's history of traumatic brain injury. Baseline and follow-up versions will be administered.
3 months, 30 months
Ontario Child Health Study Emotional Behavioural Scales - Brief
Časové okno: Baseline, 6 months, 24 months
The Ontario Child Health Study Emotional Behavioural Scales - Brief (OCHS-EBS-B) is a 25-item measurement tool for participants under the age of 18 that assesses common child/youth mental health disorders within the last 6 months. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.
Baseline, 6 months, 24 months
Patient Global Improvement Scale
Časové okno: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The Patient Global Improvement Scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status. Scores range from 0 to 7, with lower scores reflecting more positive symptoms and thus improvement in clinical status.
Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Patient Health Questionnaire
Časové okno: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
The Patient Health Questionnaire (PHQ) is a self-administered version of the Primary Care Evaluation of Mental Disorders (PRIME-MD) diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as 0 (not at all) to 3 (nearly every day).
Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
Pittsburgh Sleep Quality Index
Časové okno: Baseline
This assessment is designed to evaluate the overall sleep quality in a clinical population. It is a 19-item self-reported questionnaire assessing seven subcategories; use of sleeping medication, subjective sleep quality, sleep latency, duration, sleep efficiency, disturbances and dysfunction during the daytime. Each subcategory ranges from scores of 0 to 3, with higher scores reflecting poorer sleep patterns.
Baseline
Phlebotomy (blood) collection
Časové okno: Baseline, 12 months, 24 months

Blood will be collected by a trained phlebotomist or research nurse with experience working with children and youth. Blood will be collected at baseline, and then annually. A maximum of 40 mL of blood will be collected per participant; however, sites may collect reduced volumes due to site-specific procedures and/or participant limitations. To ensure sufficient sample volumes for clinical and genetic/immune analyses, a minimum collection threshold will be applied to each.

Clinical testing (7-20 mL): Samples will be transferred to clinical labs for CBC, differential white cell count, HbA1C, CRP, glucose, and lipid testing.

Genetic and immune analysis (16-20 mL): Samples will be analyzed for genetic, epigenetic, and immune markers.

Sites will aim to collect the full 20 mL for both clinical and genetic testing whenever possible.
Baseline, 12 months, 24 months
Physical Exam (Height, Weight, Body Mass Index, Waist Circumference, Neck Circumference, and Blood Pressure)
Časové okno: Baseline, 12 months, 24 months, 36 months
A physical exam will be completed by trained research or clinical staff during the clinic visit. If the participant is unable to attend the clinic visit, research staff will use recent values from their medical record or provide instructions to the participant for measuring their height, weight, waist circumference and neck circumference at home (blood pressure will not be measured at home).
Baseline, 12 months, 24 months, 36 months
PRIME- Revised
Časové okno: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 42 months
This is a self-administered questionnaire that is designed to assess individuals at risk for developing a psychotic disorder. It contains 12 items that assess positive symptoms on a distress scale ranging from 0 (Definitely disagree) to 6 (Definitely agree).
Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 42 months
Revised Child Anxiety and Depression Scale
Časové okno: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
The Revised Child Anxiety and Depression Scale (RCADS-25) is a self-report questionnaire that assesses symptoms of depression and anxiety in children and adolescents. This assessment captures symptoms related to generalized anxiety disorder (GAD), major depressive disorder (MDD), panic disorder, social phobia, separation anxiety disorder (SAD), and obsessive-compulsive disorder (OCD).
Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
Saliva collection
Časové okno: Baseline, 12 months, 24 months
Participants will be asked to provide a saliva sample to be used for genetic and epigenetic analyses. A saliva collection kit, such as that made by Oragene, will be used. Approximately 1.5 mL of saliva is provided when someone 'spits' into the collection tube. Cheek cells in saliva contain the DNA that will ultimately be extracted and processed.
Baseline, 12 months, 24 months
The Short Warwick-Edinburgh Mental Well-being Scale
Časové okno: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) uses seven statements about thoughts and feelings to monitor mental wellbeing. The seven statements are positively worded with five response categories from 'none of the time' to 'all of the time'. Children and young people are asked to describe their experiences over the past two weeks.
Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The Social Communication Questionnaire
Časové okno: Baseline
The Social Communication Questionnaire (40-item parent questionnaire), which is based on the Autism Diagnostic Interview-Revised, will be used to measure current and developmental social communication deficits. This parent-report questionnaire provides information regarding social communication and repetitive behaviours present currently and from early childhood. Total scores can range from a minimum of 0 to a maximum of 39, with higher scores indicating stronger social communication.
Baseline
Social Responsiveness Scale (SRS) - Short Form
Časové okno: Baseline, 12 months, 24 months, 30 months, 42 months
The Social Responsiveness Scale measures the severity of autism symptoms in a quantitative manner, both among children affected by symptoms that fall under the spectrum of autism as well as among children in the general population. Caregivers will complete the caregiver report school short form. Total scores can range from a minimum of 16 to a maximum of 64, with higher scores indicating lower social responsiveness.
Baseline, 12 months, 24 months, 30 months, 42 months
Strengths and Weaknesses of Attention-Deficit/Hyperactivity (SWAN) Disorder Symptoms and Normal Behavior scale
Časové okno: Baseline, 6 months, 12 months, 18 months, 24 months
The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior scale assesses ADHD symptoms in the clinical and non-clinical population. It includes a set of 18 questions and a child's behavior is scored on a 7-point scale with 4 (average) reflecting a normal behavior for the child's age. The first 9 items are associated with inattentive ADHD and the next 9 items are associated with hyperactive/impulsive ADHD.
Baseline, 6 months, 12 months, 18 months, 24 months
Suicidal Ideation Questionnaire-Junior
Časové okno: Baseline, 3 months, 12 months, 24 months, 30 months, 42 months
The Suicidal Ideation Questionnaire-Junior (SIQ-JR) consists of 15 items and will be completed by all youth in this study. It is designed for students in Grades 7-9. This assessment assists in informing adults/professionals of their levels of distress and suicidal intent without self-injurious behaviour. The overall aim of this measure is to assess suicidal ideation and risk.
Baseline, 3 months, 12 months, 24 months, 30 months, 42 months
Toronto Obsessive-Compulsive Scale - Brief
Časové okno: Baseline, 6 months, 12 months, 18 months, 24 months
The Toronto Obsessive-Compulsive Scale (TOCS) is a 21-item parent or self-report questionnaire that assesses symptoms pertaining to Obsessive-Compulsive traits among children or adolescents. Total scores can range from a minimum of -72 to a maximum of 72, with higher scores indicating the presence of more Obsessive-Compulsive traits.
Baseline, 6 months, 12 months, 18 months, 24 months
Unmet Needs Questionnaire
Časové okno: 12 months, 24 months, 36 months
The Unmet Needs Questionnaire measures the services participants are receiving and whether their needs are being met.
12 months, 24 months, 36 months
Youth Life Interference Scale
Časové okno: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The Youth Life Interference Scale (YLIS) is an 11-item self-report measure assessing the impact of mental health symptoms on day-to-day functioning in the past two weeks. The measure was developed in-house for the TAY study. Its focus lies on functional impairment related to anxiety and depression for youth. Total scores can range from a minimum of 0 to a maximum of 36, with higher scores indicating greater functional impairment.
Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Kiddie Schedule for Affective Disorders and Schizophrenia
Časové okno: Baseline, 24 months
The Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) is a widely used structured diagnostic interview that will be administered to participants in order to determine the presence of categorical mental health diagnoses. The K-SADS will be used for participants less than 18 years of age.
Baseline, 24 months
Prodromal Questionnaire - Brief
Časové okno: Baseline
This is a self-report screening measure for psychosis risk syndromes. It records psychosis-like symptoms that would have occurred over the past month. For each item in the questionnaire that is endorsed, responses range in levels of distress or impairment from a scale of 1 (strongly disagree) to 5 (strongly agree).
Baseline
Structured Interview for Prodromal Symptoms (SIPS) Negative/Disorganized Subscales
Časové okno: Baseline
The Structured Interview for Prodromal Symptoms Negative/Disorganized Subscales is a diagnostic semi-structured interview used to assess the severity of symptoms and diagnose prodromal syndromes.
Baseline
The Adolescent Alcohol and Drug Involvement Scale
Časové okno: Baseline
The Adolescent Alcohol and Drug Involvement Scale (AADIS) Revised is a self-report measure of adolescent problematic substance abuse, and will be used to quantify frequency of past-year substance use (including cannabis use). This scale also provides a numerical score derived from items related to behaviors associated with problematic use. Total scores can range from a minimum of 0 to a maximum of 84, with higher scores indicating more frequent use of substances.
Baseline
Assessment of Educational Attainment
Časové okno: Baseline
Participants will be asked to fill in a self-report questionnaire measuring educational attainment which takes about 5 minutes to complete. The revised Educational Attainment Questionnaire will assess level of education, grades and accommodations or other support at school among other education-related items. Participants fill in the Educational Attainment Questionnaire at baseline. The Educational Attainment Questionnaire is composed of several items from the School Mental Health Survey that is part of the Ontario Child Health Study, a longstanding prospective study on the overall health of children in Ontario.
Baseline
Social Responsiveness Scale - Long Form
Časové okno: Baseline
Autism spectrum symptoms will be evaluated using the long form of the Social Responsiveness Scale (SRS-2), which is a validated brief measure of autism traits consisting of 65 items. Caregivers will complete the caregiver report school version. Total scores can range from a minimum of 65 to a maximum of 260, with higher scores indicating the presence of more autism traits.
Baseline
Columbia Impairment Scale
Časové okno: Baseline
The Columbia Impairment Scale (CIS) is a 13-item self and caregiver report scale which provides a global measure of impairment in 4 major areas of functioning: interpersonal relations (family and friends), broad psychopathological domains, job or school functioning, and use of leisure time. Total scores can range from a minimum of 0 to a maximum of 52, with higher scores indicating more global impairment.
Baseline
Global Functioning: Social and Role Scales - Brief
Časové okno: Baseline
The Global Functioning: Social and Role Scales assessment measures social and role functioning through a semi-structured interview. Total scores can range from a minimum of 1 to a maximum of 10, with higher scores indicating greater functioning.
Baseline
Self-report World Health Organization - Disability Assessment Schedule
Časové okno: Baseline
The Self-report World Health Organization - Disability Assessment Schedule is a 12-item generic assessment instrument for health and disability. This tool produces standardized disability levels and profiles directly linked at the level of the concepts to the International Classification of Functioning, Disability and Health (ICF), and covers six domains of functioning: cognition, mobility, self-care, getting along, life activities, and participation. Total scores can range from a minimum of 0 to a maximum of 48, with higher scores indicating lower functioning.
Baseline
Health and Social Service Utilization measure
Časové okno: 6 months
Youth will be asked to self-report their mental health and other health and social service utilization using an adapted version of the Health and Social Service Utilization measure that has been previously used with this population, including in the current Longitudinal Youth in Transition Study at the Centre for Addiction and Mental Health (CAMH). Additional items are adapted from the Ontario Student Drug Use and Health Survey.
6 months
Transition Readiness Assessment Questionnaire
Časové okno: 6 months
The Transition Readiness Assessment Questionnaire (TRAQ) will be used to assess the transition readiness of youth between the ages of 15 and 19 from youth to adult mental health services. Total scores can range from a minimum of 20 to a maximum of 100, with higher scores indicating greater transition readiness.
6 months
Internet Addiction Test
Časové okno: Baseline
The Internet Addiction Test measures the presence and severity of problematic internet use across six addictive domains: Conflict, Mood Modification, Salience, Tolerance, Relapse, and Withdrawal.
Baseline
Parent Child Internet Addiction Test
Časové okno: Baseline
The Parent Child Internet Addiction Test measures the presence and severity of problematic internet use. This test is a 20-item measure asking the parent to indicate the frequency of behaviours in the child on a 6-point scale ranging from 'Does not apply' to 'Always'.
Baseline
Leisure Time Questionnaire
Časové okno: Baseline, 6 months
The Leisure Time Questionnaire is used to assess time spent in leisure activities.
Baseline, 6 months
MRI Scan
Časové okno: Baseline
Youth participants enrolled in the deep phenotyping cohort will be asked to complete an MRI scan at their participating site for approximately 1 hour. Each scan will consist of high-quality T1-weighted, diffusion MRI (dMRI) and r-fMRI sequences that will be combined into a single neuroimaging output per participant.
Baseline
Edinburgh Handedness Inventory - Brief
Časové okno: Baseline
The Edinburgh Handedness Inventory (EHI) - Brief is a four-item questionnaire used to assess laterality. Youth are asked to report the dominance of the right or left hand in everyday activities. Scores range from -100 (indicating left preference) to 100 (indicating right preference).
Baseline
The Snellen Chart
Časové okno: Baseline
The Snellen Chart is an eye chart commonly used to assess visual acuity using eleven lines of block letters. Participants are asked to stand ten feet from the chart and to read the letters of each row aloud, beginning from the top row.
Baseline
Toolbox Dimensional Change Card Sort Task
Časové okno: Baseline
The Toolbox Dimensional Change Card Sort Task assesses cognitive flexibility. Youth are presented with two stimuli at the bottom of the screen and asked to sort a third stimulus presented in the middle of the screen to match one of the two stimuli at the bottom, by either colour or shape.
Baseline
Toolbox Flanker Task
Časové okno: Baseline
The Toolbox Flanker Task assesses attention and inhibitory control. Youth are presented with a target stimulus and two surrounding flanker stimuli, and are asked to indicate which direction the middle stimulus is facing (left or right); surrounding flanker stimuli may be facing in the same direction (congruent trials) or the opposite direction (incongruent trials).
Baseline
Toolbox List Sorting Working Memory Test
Časové okno: Baseline
The Toolbox List Sorting Working Memory Test assesses working memory sequencing skills. Youth are presented with animals and foods of assorted sizes both visually and auditorily, and asked to list the items presented from smallest to largest. This test is repeated using items from a single category, and items from two categories; in the latter, youth are requested to list items from one category and then the other.
Baseline
Toolbox Oral Reading Recognition Task
Časové okno: Baseline
The Toolbox Oral Reading Recognition Task assesses language exposure and reading skills. Youth are asked to pronounce visually presented letters or words.
Baseline
Toolbox Pattern Comparison Processing Speed Test
Časové okno: Baseline
The Toolbox Pattern Comparison Processing Speed Test assesses visual processing. Youth are asked to determine whether two visually presented pictures are the same.
Baseline
Toolbox Picture Sequence Memory Test
Časové okno: Baseline
The Toolbox Picture Sequence Memory Test assesses episodic memory. Youth are presented with 15 pictures demonstrating events and are asked to model those events as a series of actions using props.
Baseline
Toolbox Picture Vocabulary Task
Časové okno: Baseline
The Toolbox Picture Vocabulary Task assesses language and verbal intellect. Participants are auditorily presented with a word and asked to choose which of four visually presented pictures matches that word.
Baseline
Rey Auditory Verbal Learning Test
Časové okno: Baseline
The Rey Auditory Verbal Learning Test (RAVLT) assesses auditory learning and memory. Youth are asked to listen to and recall a list of 15 unrelated words over five learning trials. They are then presented with and asked to recall as many words from a second, distractor list of 15 words, and recall of the initial list is then assessed.
Baseline
Wechsler Intelligence Test for Children-V Matrix Reasoning
Časové okno: Baseline
This subtest of the Wechsler Intelligence Scale for Children assesses nonverbal reasoning, as well as visual intelligence, part-whole spatial reasoning, perceptual organization, attention to visual detail, and sequencing. Youth are presented with an incomplete array of visually presented stimuli, and asked to select one of four alternatives to complete the array. For participants aged 16 years or over, the Wechsler Adult Intelligence Scale-IV (WAIS-IV) version of this task will be administered.
Baseline
Little Man Task
Časové okno: Baseline
The Little Man Task (LMT) assesses visual-spatial processing, including mental rotation. Youth are asked to indicate which hand a figure is using to hold a briefcase after being presented with the figure in one of four positions.
Baseline
Delay Discounting Task
Časové okno: 6 months
Delay discounting can be defined as the depreciation of the value of a reward related to the time that it takes to be released. The task is an index of impulsive behaviour. Participants play a game in which they make a choice between an immediate small reward and a delayed larger reward.
6 months
Emotional Stroop Task
Časové okno: 6 months
The Emotional Stroop Task is a modified version of the traditional Stroop task in which participants are required to name the ink color of words with emotional or neutral valence. This task is commonly used to measure the attentional biases toward emotional stimuli typically observed in humans.
6 months
Penn Emotion Differentiation Task
Časové okno: 6 months
The Penn Emotion Differentiation Task measures the social cognition domain of emotion identification - the ability to decode and correctly identify facial expressions of emotion. Youth are shown 40 faces and must determine whether the emotion expressed is happiness, sadness, anger, fear, or none at all.
6 months
The Awareness of Social Inference Test (TASIT) - Short Version
Časové okno: 6 months
The Awareness of Social Inference Test (TASIT) - Short Version measures social cognition using videos of naturalistic everyday conversations in which two actors interact. It has established ecological validity, reliability and construct validity. Alternate forms are available for re-testing.
6 months
Parental Bonding Instrument
Časové okno: Baseline
The Parental Bonding Instrument (PBI) was designed to measure the contribution of parental behavior to the development of appropriate bonds between parents and children. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.
Baseline
Personality Inventory for DSM-5 Faceted Brief Form
Časové okno: 6 months
The Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) will be used to examine maladaptive personality traits. The PID-5-FBF is a 100-item self-rated personality trait assessment scale for adolescents and adults. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.
6 months
Competitive Sports Questionnaire
Časové okno: 6 months
This is an 8-item questionnaire originally developed for the TAY study.
6 months
International Physical Activity Questionnaire
Časové okno: 6 months
This measure is a questionnaire measuring physical activities in the last 7 days.
6 months
Pain Questionnaire
Časové okno: 6 months
This measure assesses types of pain and frequency, and the impact of pain on 5-point Likert scales. For each pain item the participant needs to indicate if pain can be explained by a physical accident or diagnosed medical condition.
6 months
Puberty Development Scale
Časové okno: 6 months
This scale contains five items, with the last two items being different for males and females. It assesses the presence of developmental changes associated with puberty. Total scores can range from a minimum of 5 to a maximum of 20, with higher scores indicating the presence of more developmental changes.
6 months
Social Media Addiction Questionnaire
Časové okno: Baseline
The Social Media Addiction Questionnaire (SMAQ) is comprised of questions adapted from the Ontario Student Drug Use and Health Survey. These questions will be used to collect information on screen time use, problematic social media use and video game use, respectively, as reported by the youth participant. Total scores can range from a minimum of 6 to a maximum of 36, with higher scores indicating more problematic use of social media.
Baseline
Acculturation Questionnaire
Časové okno: 6 months
The Acculturation Questionnaire will be used to measure speaking and reading skills in English and language preference. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.
6 months
Mexican American Cultural Values Scale
Časové okno: 6 months
The Mexican American Cultural Values Scale (50 items) is used to assess family values of individuals from diverse cultural backgrounds. Total scores can range from a minimum of 50 to a maximum of 250, with higher scores indicating less adherence to the outlined cultural values.
6 months
Multigroup Ethnic Identity-Revised
Časové okno: 6 months
The Multigroup Ethnic Identity-Revised will be used to measure cultural affiliation. This measure contains 6 items that can be rated on a five-point scale from strongly disagree to strongly agree. Total scores can range from a minimum of 6 to a maximum of 24, with higher scores indicating stronger cultural affiliation.
6 months
Vancouver Index of Acculturation - Short
Časové okno: 6 months
The Vancouver Index of Acculturation - Short will be used to measure acculturation with 20 items that can be rated from disagree to agree on a 9-point scale. Total scores can range from a minimum of 10 to a maximum of 90, with higher scores indicating greater acculturation.
6 months
Parental Monitoring
Časové okno: 6 months
Family and social influences including parental monitoring and interactions with family members will be measured using the Parental Monitoring questionnaire. Total scores can range from a minimum of 5 to a maximum of 25, with higher scores indicating higher parental involvement.
6 months
Prosocial Scale from the Strengths and Difficulties Questionnaire
Časové okno: 6 months
Family and social influences including prosocial behaviors and interactions with family members will be measured using the Prosocial Scale. Total scores can range from a minimum of 0 to a maximum of 10, with higher scores indicating more prosocial behaviors.
6 months
Conflict Behavior Questionnaire
Časové okno: 6 months
Family and social influences including interactions with family members will be measured using the Conflict Behavior Questionnaire. Total scores can range from a minimum of 0 to a maximum of 20, with higher scores indicating the presence of more conflict-related behaviors.
6 months
Gender Dysphoria Questionnaire for Adolescents and Adult
Časové okno: 6 months
In addition to self-reported gender obtained using the demographic protocol, gender expression will be measured using the Gender Dysphoria Questionnaire for Adolescents and Adults. Total scores can range from a minimum of 27 to a maximum of 135, with higher scores indicating greater satisfaction and less gender-related distress.
6 months
Personal Attributes Questionnaire
Časové okno: 6 months
In addition to self-reported gender obtained using the demographic protocol, gender identity variability will be measured using the Personal Attributes Questionnaire. Total scores can range from a minimum of 0 to a maximum of 96, with higher scores indicating stronger self-perceptions of gender attributes.
6 months
Adverse Life Events Scale
Časové okno: 6 months
Life events and current life stress will be assessed in all participants below age 18 using The Adverse Life Events Scale. Total scores can range from a minimum of 0 to a maximum of 25, with higher scores indicating more adverse life events and/or related stress.
6 months
Childhood Trauma Questionnaire - Short Form
Časové okno: 6 months
All participants will be administered the Childhood Trauma Questionnaire - Short Form to identify traumatic childhood conditions. Total scores can range from a minimum of 28 to a maximum of 125, with higher scores indicating greater exposure to traumatic childhood conditions.
6 months
Connor-Davidson Resilience Scale
Časové okno: 6 months
Individual resilience in the face of stress will be measured using a brief, two-item version of the Connor-Davidson Resilience Scale. Total scores can range from a minimum of 0 to a maximum of 8, with higher scores indicating higher resilience.
6 months
Everyday Discrimination Scale
Časové okno: 6 months
Lifetime discriminatory experiences will be assessed in all participants using a Canadian adaptation of the Everyday Discrimination Scale. Total scores can range from a minimum of 5 to a maximum of 25, with higher scores indicating greater discriminatory experiences.
6 months
Life Events Checklist
Časové okno: 6 months
The Life Events Checklist (LEC) is designed to screen for potentially traumatic experiences that may contribute to psychological distress. Participants aged 18 and above will be administered the Life Events Checklist.
6 months
Inventory for School Risk and Protective Factors
Časové okno: 6 months
All participants' school environments will be characterized using the Inventory for School Risk and Protective Factors measure from the ABCD study. Total scores can range from a minimum of 6 to a maximum of 24, with higher scores indicating greater protective factors.
6 months
Neighbourhood Safety and Crime Scale
Časové okno: 6 months
In the proximal social environment, neighbourhood safety will be measured using a three-item Neighbourhood Safety and Crime Scale. Total scores can range from a minimum of 3 to a maximum of 15, with higher scores indicating lower perceived neighbourhood safety.
6 months
3-Digit Postal Codes
Časové okno: Baseline
3-digit postal codes of participants (collected as part of routine demographic data) will be used to obtain census-based neighbourhood-level marginalization data; this will allow each participant's neighbourhood to be characterized by the level of social and economic marginalization as well as ethnic concentration. At the time of cohort entry, the first 3 digits of each participant's postal code are collected based on the participant's residential address. Any change in a participant's residential address will also be recorded during assessment periods during the study to account for changes in exposure to socio-environmental factors.
Baseline
Parent General Behaviour Inventory-10 Mania
Časové okno: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
Caregivers will complete the Parent General Behaviour Inventory-10 Mania, which measures the presence and severity of mania. Total scores can range from a minimum of 0 to a maximum of 30, with higher scores indicating greater presence and severity of mania.
Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
Video Game Addiction Questionnaire
Časové okno: Baseline
The Video Game Addiction Questionnaire (VGAQ) is comprised of questions adapted from the Ontario Student Drug Use and Health Survey. These questions will be used to collect information on screen time use, problematic social media use and video game use, respectively, as reported by the youth participant. Total scores can range from a minimum of 6 to a maximum of 36, with higher scores indicating more problematic use of video games.
Baseline
Student Adaptation to College Questionnaire
Časové okno: Baseline
The Student Adaptation to College Questionnaire (SACQ) is a self-report questionnaire measuring educational attainment. Participants attending post-secondary school will also be asked to complete the SACQ. Total scores can range from a minimum of 67 to a maximum of 603, with higher scores indicating better overall adjustment to college life.
Baseline

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Centre for Addiction and Mental Health

Spolupracovníci

Ontario Brain Institute

Vyšetřovatelé

  • Vrchní vyšetřovatel: Louise Gallagher, MB, BCh, PhD, Centre for Addiction and Mental Health
  • Vrchní vyšetřovatel: Paul Arnold, MD, PhD, University Of Calgary
  • Vrchní vyšetřovatel: Gary Goldfield, PhD, C. Psych., The Children's Hospital of Eastern Ontario Research Institute
  • Vrchní vyšetřovatel: Stephanie Ameis, MD, MSc, Centre for Addiction and Mental Health
  • Vrchní vyšetřovatel: Suneeta Monga, MD, FRCPC, The Hospital for Sick Children
  • Vrchní vyšetřovatel: Melissa Kimber, PhD, MSW, RSW, Hamilton Health Sciences Corporation
  • Vrchní vyšetřovatel: Jennifer Phillips, PhD, The University of Ottawa Institute of Mental Health Research at the Royal
  • Vrchní vyšetřovatel: Nicole Racine, PhD, C. Psych., The Children's Hospital of Eastern Ontario Research Institute

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

4. března 2025

Primární dokončení (Odhadovaný)

31. března 2028

Dokončení studie (Odhadovaný)

31. března 2028

Termíny zápisu do studia

První předloženo

24. června 2026

První předloženo, které splnilo kritéria kontroly kvality

7. července 2026

První zveřejněno (Aktuální)

13. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

7. července 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • 4792

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

De-identified data from this project may be used for future research by internal project collaborators. De-identified and anonymized data from this research study will be deposited to site specific database repositories for future use.

Data will be shared with third-parties for secondary use via the Brain-CODE Platform. Third-parties will own the derived outputs such as new data and analyses (the Work Product) that result from their use of the data.

Ontario Brain Institute - Brain-CODE Participation Agreement:

The Centre for Ontario Data Exploration (Brain-CODE), is an informatics platform established by the Ontario Brain Institute to facilitate and expedite the investigation, discovery, or scientific query within and/or across several health conditions. All participating sites in CALM, including CAMH have signed Brain-CODE Participation Agreements with OBI agreeing to contribute data to Brain-CODE.

Časový rámec sdílení IPD

Participating sites will transfer de-identified raw data to Brain-CODE in line with the REB approval and subject to participant consent. Brain-CODE provides data storage for investigators (zone 1), long term storage of the data (Zone 2) and opportunities for data to be made available to approved third parties for further analysis, research and use (zone 3). Data transfers will occur at regular intervals from the study start date according to an agreed schedule between participating sites and Brain-CODE.

Kritéria přístupu pro sdílení IPD

Only the respective employees of OBI and the participating institutions, contractors, agents, collaborators, and any authorized Study staff from other sites that are part of the same study will provide have access to data in zone 1 consistent with the REB approved protocol, the Brain-CODE Participation Agreement and the Study Description Schedule. OBI undertakes to not use Data to identify or attempt to identify any study participants or other individuals from de-identified data.

Secure password protected access is provided to all participating institutions in CALM. Passwords will be confidential and available only to authorized personnel at these participating institutions. These institutions will notify Brain-CODE immediately of an unauthorized transfer, use, access, or disclosure of Data or having knowledge that a Password may have been compromised in any way which may permit an unauthorized person or entity to access Brain-CODE or any associated sites or databases.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • ICF
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Drogové intervence

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Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

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